Wound protecting and fixing device

ABSTRACT

A wound protecting and fixing device includes at least a protecting and fixing layer ( 1 ) with an opening. The opening ( 11 ) is defined in the protecting and fixing layer and configured to extend between an upper plane and a lower plane of the protecting and fixing layer along a longitudinal direction, and to surround a wound therein so that the protecting and fixing layer ( 1 ) with the opening limits an increase of tension at the wound and a movement-incurred wrinkle of skin at the wound. The protecting and fixing layer ( 1 ) with the opening includes a flexible protecting and fixing layer ( 1   a ) with an opening and a rigid protecting and fixing layer ( 1   b ) with an opening. The device can prevent the wound from being ripped and ruptured, and prevent damages caused by movement-incurred wrinkles of the skin at the wound and relative displacement frictions.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of International PCT Application No.PCT/CN2012/071199, filed on Feb. 16, 2012, which claims the benefit ofChinese Patent Application No. 201110403898.3 filed on Dec. 7, 2011, nowChinese Patent No. CN 102429769B; the contents of which are herebyincorporated by reference.

FIELD OF THE PATENT APPLICATION

The present patent application relates to the field of medical assistivedevices and technologies, and more specifically to a wound protectingand fixing device.

BACKGROUND

In people's lives, due to harms caused by many factors, the human bodymay incur wounds such as external injury wounds, surgical wounds,infusion wounds, and so on. A wound, once incurred, must be protectedand tended so that severe complications caused by wound infections canbe prevented. Hence excellent wound protection and care technologies andproducts are critically important to expedite the healing of wounds.Currently in clinical medicine, a wound is protected and tended mainlythrough wound dressings. Such products mainly include spunlace non-wovencloths, transparent thin film dressings, foam dressings, hydrocolloiddressings, functional dressings, and etc. To achieve better results,different types of dressings are used to protect and tend differenttypes of wounds. If the protecting and tending methods, technologies andproducts are inappropriate, the damages to the wound will be aggravated.Therefore, attention should be paid to the wound damage aggravationcaused by current wound protecting and tending technologies and productsduring protecting and tending wounds, or the failure of achievingoptimal protecting and tending effects caused by functional defects ofthe products. To create new products with better healing effects, basedon the characteristics of wounds to be tended, a simple categorizationof the wounds is made, while advantages and disadvantages of theconventional technologies and products in protecting and tending thewounds are analyzed and compared.

The first type of wounds is that with infusion catheters. In tendingthis type of wounds, such as wounds with central venous catheters,peripherally inserted central catheters, and vein retaining needlecatheters, besides that the catheter must be securely fixed, the woundneeds to be specially protected to prevent infection, and in some cases,the catheter needs to be retained for as long as a few months so as tocure the disease. Currently a clinically preferred method is to usetransparent thin film dressing (PU film) to directly cover the infusionwound and fix the catheter, with the advantages of:

1. The dressing being super thin and transparent, so that the wounddevelopment status can be observed any time;

2. Excellent flexibility and conformability with the skin. Once thedressing is affixed to the skin, it is hard to separate the dressing andthe skin.

Therefore, compared with dressings made of other materials, suchdressing is more secure and less likely to fall off in fixing thecatheter and protecting the infusion wound. However, the dressing hasthe following disadvantages:

1. Because of its good flexibility, along with a movement-incurredwrinkle of the superficial skin, the dressing will generate the samemovement-incurred wrinkle and not be able to prevent themovement-incurred wrinkle of the skin. As a result, when the superficialskin generates a movement-incurred wrinkle under an external force orcaused by a body movement, the catheter will have a displacement therebydamaging the infusion wound;

2. The adhesive is sealed on the infusion wound, which may cause allergyat the wound or skin around the wound and generate inflammatoryresponses such as contact dermatitis;

3. The dressing is not sweat permeable, so that sweat may accumulate atthe wound or under the thin film, which may easily cause woundinfections, even secondary severe complications such as phlebitis, orbloodstream infection;

4. The dressing needs to be changed in 3 to 6 days. Not changing thedressing and subsequently sanitizing the wound for a period longer thanthat may cause infection.

The second type of wounds are regular wounds such as surgical wounds,external injury wounds and etc. Clinically this type of wounds arenormally handled by using spunlace non-woven cloths with pads orcushions, foam dressings, hydrocolloid dressings and so on to tend andprotect the wounds. This type of dressings have the followingadvantages:

1. The dressings have strong absorbency. They can absorb wound exudationand prevent the expansion of the infection area.

2. There is no adhesive in direct contact with the wound.

3. The hydrocolloid dressings can keep the wound tissues moist andexpedite the healing.

However, such dressings have the following disadvantages:

1. The dressings are not transparent (the hydrocolloid is translucent),as a result, the development status of the wound cannot be observed anytime.

2. Compared with transparent thin film dressings, such dressings haveweaker flexibility and conformability, and stronger hardness andrigidity. Under tension, the dressing can easily fall off from thesurface of the skin, thereby having lower fixity. When the dressing isconformed to wounds at movable joint parts of the body wheremovement-incurred wrinkles may easily be generated, or when the patientis sweating as a result of movement, the dressing may easily fall off.

3. The dressings have bad waterproofness, or is not waterproof at all.The adhesive layer of the dressing may easily fall off from the skinwhen being in contact with water.

4. When the superficial skin of the wound has a movement-incurredwrinkle, there may be friction caused by relative displacement betweenthe superficial skin of the wound and the pad or cushion as well as thedressing that the wound directly contacts, so that further damage may becaused to the wound tissues, especially for wounds at movable jointparts of the body.

In addition, the above-mentioned dressings are in direct contact withand pressingly covered upon the wound, and therefore may conglutinatewith the secretion of the wound tissue. When the dressing is changed,further damage may be caused to the wound tissue. Althoughnon-conglutination technical processing is applied to the part of thedressing which contacts the wound, but the non-conglutination is onlyrelative. At the same time, when a sanitization processing is made tothe wound from time to time, all of the above-mentioned dressings haveto be changed as a whole.

In addition to the above-mentioned technologies, currently, somedressings that prevent tissue adherence or “non-contact” woundprotecting and tending devices such as “covers”, “frames” and otherwound protecting and tending technologies, have appeared, but theseanti-tissue-adherence materials can not completely prevent tissueadherence, or tissue rejection and inflammatory reactions against theforeign bodies. In addition, the wound protecting and tending devicessuch as the “covers” and the “frames” have complex structures. Lackingan effective fixing method, such devices are hard to be stably fixed andmay easily move so as to cause further damages to the wound. Suchdevices cannot be applied to the fixation of central venous catheters,peripherally inserted central catheters, and vein retaining needlecatheters, or to the protecting and tending of infusion wounds.Furthermore, the manufacture and application of such devices arerelatively complicated. Hence it is difficult to widely promote theapplication of such devices clinically.

In addition to the above-mentioned disadvantages of the conventionaltechnologies and methods for wound protecting and tending, theconventional technologies and methods cannot prevent the wound frombeing ripped and ruptured under an external force or tension. Currently,there are no clinically effective methods or technologies to addresswound ripping and rupture, especially for surgical wounds and externalinjury wounds at the abdomen and movable joint parts. Ripping andrupture caused by coughing, postoperative abdominal distension, forciblyurination and defecation, and so on, may severely affect the woundhealing and cause complications such as infection.

Whether the adhesion between a wound protecting and tending product andthe surface of the skin is secure is also an important factor thatdetermines the effect of wound protecting and tending. Therefore, thephysiological characteristics of the human superficial skin determineand influence the effects of the wound protecting and tending product.The human skin has the following physiological characteristics:

1. The skin is an organ that secretes sweat. The sweat being secretedwill reduce the adhesiveness of the protecting and fixing adhesivelayer, and even make it fall off;

2. The skin has a relatively soft surface, which moves and produceswrinkles along its texture under an external force, especially at jointparts with movement functions. The older the age, more wrinkles thereare, and more easily the wrinkles may be produced. Therefore, when arigid protecting and fixing adhesive layer that can relatively hardlywrinkle or cannot wrinkle adheres to the surface of the skin, and whenthe adhering surface undergoes a tension produced by movement-incurredwrinkles being created under an external force, it will first resist thetension of the movement-incurred wrinkles so as to limit thedisplacement and the wrinkling of the surface of the skin. When theadhering force is not enough to resist the tension, the adhering surfacewill peel and fall off. Therefore, when only using the rigid fixingadhesive layer to bond and secure an object on the surface of the skin,the advantage is that it can resist the tension of the movement-incurredwrinkles of the skin so as to limit the movement-incurred wrinkles onthe adhering surface or the surface of the skin surrounded by theopening thereof. However, the disadvantage is because it requires theadhering force with the skin to resist the tension of themovement-incurred wrinkles of the skin, when the adhering force is notenough to resist the tension of the movement-incurred wrinkles of theskin, or when the tension with the adhesive surface of the skinincreases, the rigid protecting and fixing adhesive layer will peel andfall off. On the other hand, when a flexible protecting and fixingadhesive layer adheres to the surface of the skin, because it is soft,ultra-thin, and has good conformability, it may generate the samemovement-incurred wrinkles as the movement-incurred wrinkles of the skintextures, and keep a good adherent state with the skin under anymovement-incurred wrinkle conditions. Hence, the tension of themovement-incurred wrinkles of the skin is not against the adheringforce. When using a flexible protecting and fixing adhesive layer toprotect and fix medical items or wounds at the surface of the skin, theadvantage of it is that the adhesion is tight and secure, and even whenthere is sweat, it will not fall off easily. The disadvantage of it isthat the medical items or the wound that the protecting and fixingadhesive layer is protecting and fixing generates displacements andmovement-incurred wrinkles along with the movement-incurred wrinkles ofthe surface of the skin. For a catheter fixture with an infusion openingor a fixture with wound dressing, the catheter at the infusion openingwill move while the surface of the wound will generate movement-incurredwrinkle. As a result, further damage will be caused to the wound whilethe relative displacement frictions between the wound and the dressingwill do harm to the wound tissue.

3. Skin wounds of allergic constitution will be allergic to the adhesivelayer, which leads to inflammation and infection. Hence it is necessaryto avoid the adhesive layer directly adhering to infusion wounds,surgical wounds and traumatic wounds.

Therefore, considering the advantages and disadvantages of theabove-mentioned methods and products being applied to wound protectingand tending, according to the physiological characteristics of the skin,it is necessary to develop a new method or product that inherits andintegrates the advantages of the conventional technologies and overcomesthe disadvantages, and to create a new adhering, protecting and fixingmethod and product that suit the physiological characteristics of theskin. The improved technologies, methods or products should meet thefollowing requirements:

1. being capable of effectively preventing wounds (including surgicalstitching wounds, traumatic wounds, infusion wounds and some hightension wounds) from being ripped and ruptured;

2. being capable of contacting the wound secretion in a permeating mode,instead of tightly and pressingly contacting the wound secretion, sothat the product can effectively absorb the secretion liquid of thenecrotic tissues of the wound and prevent regional spreading, with no orvery little conglutination with the wound tissue;

3. being capable of letting the wound be open and visible so that thedeveloping status of the wound can be observed any time;

4. being capable of securely fixing and adhering to skin around thewound and fixing the infusion catheter, just as using transparent thinfilm dressings alone, without being bonded to wounds or infusion woundsby the adhesives, while being transparent and visible at the same time;

5. being capable of limiting further damages to the wound caused by themovement-incurred wrinkles of the superficial skin of the wound and thedisplacement of the catheter, especially for wounds and infusion woundsat movable joint body parts or with relatively many skin wrinkles;

6. based on the requirements of the wound characteristics, being capableof completely preventing the wound surface from contacting any foreignbody (including the dressing itself) so as to prevent the wound fromhaving foreign body rejection and inflammation responses;

7. if needed, debridement, sanitization, drainage, and regional medicaland physical treatment may be conducted to the wound without changingthe wound protecting and tending product as a whole;

8. while protecting the wound, being capable of securely fixing thecatheter related to the wound so that the catheter may not easily falloff, just as using the transparent thin film dressing alone, preventingthe displacement of the catheter on the surface of the skin when usingthe transparent thin film dressing alone, and preventing the infusionwound from being damaged by catheter displacement.

9. if needed, being waterproof, air permissible and capable of keepingaway the contaminations from the external environment;

10. being capable of lowering the frequency of changing wound careproducts so as to reduce medical costs.

SUMMARY

An object of the present patent application is to provide a woundprotecting and fixing device to improve the protecting and fixing effectfor surgical wounds, traumatic wounds and infusion wounds, facilitatewound healing, and ensure the effect of clinical treatment.

To solve the above problems, the present patent application provides: awound protecting and fixing device including at least a protecting andfixing layer with an opening; wherein the opening is configured toextend between an upper plane and a lower plane of the protecting andfixing layer along a longitudinal direction throughout the protectingand fixing layer, and to surround a wound therein so that the protectingand fixing layer with the opening limits an increase of tension at thewound and a movement-incurred wrinkle of skin at the wound.

In this technical solution, the opening surrounds the surgical wound,the external injury wound and the infusion wound inside itself so thatthe protecting and fixing layer with the opening limits an increase oftension at the wound and a movement-incurred wrinkle of skin at thewound, prevents wound ripping and rupturing, and prevents damages beingdone to the wound caused by movement-incurred wrinkles of the wound skinand relative displacement frictions between the wound, the dressing andthe catheter, thereby improving the effects of protecting the wound andinfusion wound, facilitating wound healing, effectively preventinginfusion wound infection, and ensuring the effect of clinical treatment,especially for high tension surgical wounds at the abdomen, wounds atmovable joint parts of the body, and patients who needs long terminfusion therapy through venous catheters. In this technical solution, acavity is formed in the protecting and fixing layer with the opening.Through adjusting the thickness of the protecting and fixing layer withthe opening, or the height or volume of the cavity, the dressingcovering the wound contacts the wound secretion in a permeating mode,and absorbs oozed liquid of the wound, preventing further damages to thewound resulted from allergic responses caused by adhesives contact andconglutination between the dressing and the wound secretion caused byusing dressings to press and contact the wound and by directly bondinginfusion wounds in the conventional technologies, and keeping the woundand the infusion wound in an opening cavity where they cannot be touchedby any foreign object (including the dressing) so as to prevent contactinflammation from happening.

The protecting and fixing layer with the opening is made of or partiallymade of transparent thin film materials (PU film), which is transparent,waterproof, air permeable, and with good flexibility and conformability.The characteristics of this material are: the material can generate thesame movement-incurred wrinkles as the wrinkles that the texture of theskin generates, remain good flexibility and conformingly and securelyadhere to the wound, the skin around the infusion wound, and thecatheter being covered so that itself as well as the catheter cannot beeasily separated and falling off from the surface of the skin. It canalso bond other adhering objects to the surface of itself more securely.In addition, the fastness of this structure is much stronger thandirectly bonding to the skin. Covers such as plastic, silicon gel, foam,hydrocolloid, non-woven cloth, and so on, make it not easy for the wholefixing layer to be separated and falling off from the surface of theskin. The fixing is more secure, thereby protecting the wound andinfusion wound more effectively.

The protecting and fixing layer with the opening is or partially is madeof materials such as silicon gel, plastic, foam, hydrocolloid,multi-layer compressed thickened non-woven cloth, and etc. Comparingwith transparent thin films (PU film), this material has relativelystronger rigidity with the characteristics of: the material does notgenerate movement-incurred wrinkles as the skin it adheres to wrinkleswith its texture, and can effectively limit the wound surrounded by theopening and the cavity formed by the opening, the movement-incurredwrinkles of the superficial skin at the infusion wound during bodymovement or under the pulling of an external force, and the increase oftension at the wound, thereby preventing wound ripping and rupture,preventing damages done to the wound by movement-incurred wrinkles ofthe wound, and the relative displacement friction between the wound andthe dressing, limiting the movement-incurred wrinkles caused by thecatheter being bonded, the surface of the skin and other protectinglayers, and preventing the catheter from moving and damaging the wound.

Preferably, the protecting and fixing layer with the opening includes aflexible protecting and fixing layer with an opening and a rigidprotecting and fixing layer with an opening. A cavity is defined in therigid protecting and fixing layer with the opening. In this technicalsolution, because the protecting and fixing layers with openings ofdifferent material characteristics are used, the respectivecharacteristics of protecting and fixing the wound are expressed. Theflexible protecting and fixing layer with the opening, with acharacteristic of being ultra-thin, after being bonded to the skin, maygenerate the same movement-incurred wrinkles as the superficial skinwrinkles with its texture, and preferably is made of transparent thinfilm (PU film). The rigid protecting and fixing layer with the opening,compared with the flexible protecting and fixing layer with the opening,is more rigid and thicker. After being bonded to the surface of theskin, it does not generate the same movement-incurred wrinkles as thesuperficial skin wrinkles with its texture, and does not generatewrinkles. The materials for it may be chosen based on different woundcharacteristics, which may be a soft material to satisfy the comfort ofthe skin, or may be a hard, inelastic, hard-to-deform material, such asplastic, silicon gel, foam, hydrocolloid, non-woven cloth, and etc., aslong as it does not generate the same movement-incurred wrinkles as thesuperficial skin wrinkles with its texture after being bonded to theskin. When the skin to which the flexible protecting and fixing layerwith the opening is bonded generates movement-incurred wrinkles under anexternal force, almost no tension is produced at the adhesive surfacebetween the flexible protecting and fixing layer with the opening andthe skin. Therefore, no matter how the skin generates movement-incurredwrinkles, sweats or soaks in water, the flexible protecting and fixinglayer with the opening will not separate from the surface of the skinand fall off. When the rigid protecting and fixing layer with theopening is bonded to the surface of the skin, the rigid protecting andfixing layer with the opening will resist the tension produced by theskin wrinkles and deformation, limit the skin wrinkles, and when thedisplacement force of the movement-incurred wrinkles of the skin isgreater than the adhesive force that the rigid protecting and fixinglayer with the opening staying on the skin generates, the rigid flexibleprotecting and fixing layer with the opening will be separated and falloff, which is more easily to happen when the skin sweats or soaks inwater. However, when the rigid protecting and fixing layer with theopening adheres to the flexible protecting and fixing layer with theopening that has been bonded to the skin, the adhesive force is greatlyenhanced and sufficient to resist the tension produced at the adhesivesurface by the movement-incurred wrinkles of the flexible protecting andfixing layer with the opening and the skin so that the rigid protectingand fixing layer with the opening will not separate and fall off fromthe surface of the flexible protecting and fixing layer with theopening, and not affect the secure adherence between the flexibleprotecting and fixing layer with the opening and the surface of theskin. At the same time, the rigid protecting and fixing layer with theopening can limit the movement-incurred wrinkles of the flexibleprotecting and fixing layer with the opening adhering thereto, themovement of medical items being fixed, and the movement-incurredwrinkles of the skin of the surface of the wound surrounded by theopening, thereby preventing damages from being done to the skin by themovement-incurred wrinkles of the skin of the surface of the wound,limiting the increase of tension at the wound, preventing wound rippingand rupturing, and prevent damages being done to the infusion wound bythe displacement of the catheter. In addition, because the outerboundary of the flexible protecting and fixing layer with the opening isalways larger than the outer boundary of the rigid protecting and fixinglayer with the opening, the outer boundary adhering to the skin is theflexible protecting and fixing layer, so that it generates the samemovement-incurred wrinkles as the superficial skin wrinkles with itstexture. While the same wrinkles are produced, it will not separate,peel or fall off. Therefore, by cooperatively bonding the flexibleprotecting and fixing layer with the opening and the rigid protectingand fixing layer with the opening and using them to protect and fixwound and catheters, they will be very securely fixed and not easy toseparate and fall off from the skin, and will be very stable and noteasy to produce movement. It will securely and stably fix the wholewound protecting and fixing device to the skin around the wound so thatthe optimum effect of protecting the wound is achieved, and therequirements of wound care and medical items (eg. catheters) fixationare satisfied. In this technical solution, because a cavity is formedinside the rigid flexible protecting and fixing layer with the opening,by setting up different thickness of the rigid protecting and fixinglayer with the opening or different height and volume of the cavity,only surface contact in a permeating mode between secretion at thesurface of the wound and the covering dressing is set to be allowed tofacilitate the absorption of the wound discharge, which also keeps thesurface of the wound from being contacted or pressed by any foreignobject (including dressing and other covering objects), prevents damagesfrom being imposed to the wound by the relative displacement frictionsbetween the wound and the covering dressing or the protecting and fixinglayer, and prevents, further damages from being done to the wound byadhesive contacting allergic responses and conglutination between thedressing and the wound secretion caused by using dressing to press andcontact the wound and directly bonding infusion wounds as in theconventional technology.

Preferably, an adhesive layer is disposed on a surface of the protectingand fixing layer with the opening. Through the adhesive layer, theprotecting and fixing layer with the opening is fixed on the surface ofthe skin around the wound or around the infusion wound, and theprotecting and fixing layers are bonded and fixed with each other.

Preferably, the flexible protecting and fixing layer with the opening isconfigured to follow the movement-incurred wrinkles of the texture ofthe superficial skin that the flexible protecting and fixing layeradheres to and produce the same movement-incurred wrinkles. The rigidprotecting and fixing layer with the opening is configured to limit themovement-incurred wrinkles of the skin it adheres to, movement-incurredwrinkles of the flexible protecting and fixing layer with the opening,the wound rupture surrounded by the opening, and the movement-incurredwrinkles of the superficial skin of the wound. As a result, the flexibleprotecting and fixing layer with the opening does not separate and falloff from the surface of the skin under the pulling of the tension causedby the skin movement, and is securely fixed. The rigid protecting andfixing layer with the opening can limit the movement-incurred wrinklesof the skin and the flexible protecting and fixing layer with theopening it adheres to, and the movement-incurred wrinkles of the woundrupture and the superficial skin of the wound surrounded by the opening.Therefore, it can limit the increase of the tension at the wound,prevent the wound from being ripped and ruptured, prevent damage beingdone to the wound by the movement-incurred wrinkles of the superficialskin of the wound, prevent damage being done to the wound by therelative displacement between the wound and the covering dressing or theprotecting and fixing layer, prevent damage being done to the infusionwound by the displacement of the catheter. By cooperatively bonding theflexible protecting and fixing layer with the opening and the rigidflexible protecting and fixing layer with the opening, the whole woundprotecting and fixing device does not easily fall apart from the skin orproduce displacement, and medical items being fixed such as centralvenous catheters, peripherally inserted central catheters, and veinretaining needle catheters, wound drainage tube, dialysis catheter andetc. will not move, thereby effectively protecting and fixing wounds andsecurely fixing all types of medical catheters.

Preferably, the flexible protecting and fixing layer and the rigidprotecting and fixing layer are bonded together and aligned by theopenings.

Preferably, a protecting and fixing layer with a pad and/or a protectingand fixing layer without a pad are/is disposed above the protecting andfixing layer with the opening. Such protecting and fixing layers may bemade of transparent, non-transparent, flexible and/or rigid materials,and are configured to close the opening and fix or further fix theprotecting and fixing layer with the opening onto the skin around thewound. The pad is configured to absorb the oozed liquid at the wound.

Preferably, a closing and opening member is disposed at the protectingand fixing layer with the opening. The closing and opening member isconfigured to open or close the opening.

Preferably, a pad is disposed on the lower surface of the closing andopening member and configured to be accommodated by the opening. The padmay be any type of functional pad, such as a highly absorbent pad,antiseptic pad, moisturizing pad and etc.

Preferably, the closing and opening member is detachably fixed with theprotecting and fixing layer with the opening. Such configuration makesit convenient to open and close the opening repeatedly and for a doctorto treat the wound any time according to the situation of the wound.

Preferably, the closing and opening member includes a protruding wingdisposed at an edge thereof. The configuration of the protruding wingmakes it more convenient to exert force to pull the closing and openingmember so as to save effort and time in using the device.

Preferably, a passage connecting the cavity to the outside is defined inthe rigid protecting and fixing layer with the opening, the passagebeing configured to allow an object to enter or exit the cavity. Thepassage is configured to allow medical catheters such as central venouscatheters and wound drainage tubes to pass through.

Preferably, a longitudinal cross-section of the rigid protecting andfixing layer with the opening has a trapezoid shape. The configurationin this technical solution makes other dressing and/or covering objectsbetter cover and bond the protecting and fixing layer to the skin aroundthe wound so as to achieve the optimum effect of conformity and fixture.

Preferably, the flexible protecting and fixing layer with the opening isdisposed below or above the rigid protecting and fixing layer with theopening, an outer boundary of the flexible protecting and fixing layerbeing extending beyond an outer boundary of the rigid protecting andfixing layer. When the flexible protecting and fixing layer is disposedbelow the rigid protecting and fixing layer and at the surface of theskin at the wound, the rigid protecting and fixing layer with theopening is directly bonded to the top of the flexible protecting andfixing layer with the opening. Such configuration is secure and stable,making it not easy to fall apart, and not able to move, and making theitems to be stably and securely fixed. Because the outer boundary of theflexible protecting and fixing layer with the opening extends beyond theouter boundary of the rigid protecting and fixing layer with theopening, the whole protecting and fixing layer will not peel off, orfall apart due to sweat and water soaking

Preferably, a U shaped cut is defined at an outer edge of the protectingand fixing layer with the opening. Through the configured U shaped cut,the fixing layer more effectively fixes medical tubes such as veinretaining needle catheters, drainage catheters, and etc. through theadhesive layer.

Preferably, the wound protecting and fixing device further includes asupporting member. The supporting member is fixed with at least an upperportion of the protecting and fixing layer with the opening. Thesupporting member is configured to maintain and support the coveringdressing, closing and opening member and other covering objects at theopening, so that they will not deform or collapse.

Preferably, the supporting member is a supporting bar, a supportingchip, a supporting block, or a supporting frame.

Preferably, the protecting and fixing layer with the opening is acombination of multiple layers of different materials. The combinationcan include highly absorbent materials, antiseptic materials,moisturizing materials, and materials carrying iodophor. Differentfunctional materials can be configured according to the requirements sothat an aseptic, antiseptic, growth promoting, or healing promotinginternal environment is formed in the cavity of the protecting andfixing layer with the opening.

Preferably, an outer edge of the protecting and fixing layer with theopening is connected to the opening through a slit. Through the slit,the opening or the cavity may surround the infusion wound above the skinand under the catheter, and make the upper surface of the protecting andfixing layer with the opening work as a supporting pad of the catheter.

Comparing with the conventional technology, the present patentapplication configures at least a protecting and fixing layer with anopening, which protects and fixes the wound and the infusion wound in anopening that limits the increase of tension and movement-incurredwrinkles of the superficial skin of the wound, preventing the wound frombeing ripped and ruptured, preventing the damage from being caused tothe wound by movement-incurred wrinkles of the skin at the wound and therelative displacement between the wound and the dressing or thecatheter, filling the blanks of the conventional technology. Inaddition, through adjusting the thickness of the protecting and fixinglayer with the opening or the height and volume of the cavity, theabsorbing dressing being covered or other covering objects contact thesecretion at the wound surface in a permeating mode, or the wound iskept in a state in which no foreign object can contact the wound,effectively overcoming the problems of regional skin allergy, sweataccumulation at the infusion wound under the thin film, and etc., whenusing the transparent thin film dressing including allergenic adhesivesto directly bond and cover the infusion wound of the central venouscatheter as in the conventional technologies, and thereby preventing theinflammatory response, lowering the possibility of the complication ofcatheter-related bloodstream infections (CRBSI) after the vesselcatheter is placed, preventing regional blood circulation obstructioncaused by using the cover or frame with small contact area as providedin the conventional technologies to directly press the skin around thewound; preventing the adhesives from contacting the wound and the skinaround the wound so as to reduce the occurrence of skin allergicresponses, and preventing foreign body rejection and blood circulationobstruction around the wound caused by directly contacting and pressingthe wound, according to the requirements for patients with allergicconstitution; and effectively preventing further damage from being doneto the wound by conglutination between the dressing and the woundsecretion.

Further, the protecting and fixing layer with the opening includes aflexible protecting and fixing layer with an opening and a rigidprotecting and fixing layer with an opening. The flexible protecting andfixing layer with the opening is configured to follow themovement-incurred wrinkles the skin generate along its texture andgenerate the same movement-incurred wrinkles, while the rigid protectingand fixing layer with the opening is configured to limit themovement-incurred wrinkles of the skin it adheres to, of the flexibleprotecting and fixing layer with the opening, and of the superficialskin at the wound surrounded by the opening or cavity, and the increaseof tension at the wound, thereby preventing the wound from being rippedand ruptured. By combining and using protecting and fixing layers of twodifferent material characteristics, the advantages are kept and thedisadvantages are overcome. Therefore, compared with the conventionaltechnologies, this technology enables device to be securely fixed ontothe skin around the wound, not easily fall apart, and also keep thedevice and the objects to be fixed such as the catheters and thedressings from moving on the skin, thereby effectively overcoming theproblem of the catheter damaging the infusion wound caused bymovement-incurred wrinkles of the skin or the catheter being pulled bythe tension when solely using a flexible protecting and fixing layersuch as a transparent thin film (PU film) to protect and fix an infusionwound as in the conventional technology, and effectively overcoming theproblem of the protecting and fixing layer falling apart from the skinaround the wound caused by situations such as skin tension, sweat, watersoaking and etc., when solely using a rigid fixing layer dressing suchas non-woven cloth, foam, and etc. to fix the wound and infusion woundas in the conventional technologies. At the same time, this technologyalso overcomes the disadvantages of lacking an effective fixing methodand the structure being complex for wound protecting and fixing devicessuch as the cover or frame in the conventional technologies.

Further, a closing and opening member that can be repeatedly opened andclosed is disposed on the protecting and fixing layer with the opening.The closing and opening member is configured to open or close theopening or the cavity. Such structure makes it convenient for a medicalor nursing staff to treat the wound or infusion wound, such asdebridement, repeat sanitization, drainage, and applying antiseptic andgrowth promoting medicines to the wound without changing the wholeprotecting and fixing device. Therefore, such protecting device can beused for a long time and the medical cost is saved.

Further, the closing and opening member is made of transparent materialsso that the wound and the infusion wound are transparent and visible,and the medical and nursing staff or the patient himself can observe thedeveloping status of the wound and the infusion wound any time withoutopening the closing and opening member.

Further, the protecting and fixing layer with the opening is acombination of multiple layers of different materials. Differentmaterials have different functionalities and play different roles inprotecting the wound, enhancing the effect of protection. For example, acavity formed by a protecting and fixing layer with an opening thatcarries iodophor can provide an antiseptic environment to the wound andits periphery. A cavity formed by a protecting and fixing layer with anopening that carries hydrocolloid can provide a moisture environment tothe wound so as to facilitate its growth and healing.

Further, because of the opening or/and passage that can be opened andclosed in the technical solution, through the opening or passage thatcan be opened and closed, treatment such as debridement, drainage,regional medication, regional physical treatment, nutritional treatment,growth factor treatment, negative pressure treatment, and etc. can beapplied to the wounds and infusion wounds that require differenttreatment methods, while a specific healing facilitating environment canbe created for wounds of different characteristics, such as aerobic,anaerobic, dry, moist, sterile, and antiseptic environments, so as tofacilitate fast healing of the wound.

BRIEF DESCRIPTIONS OF THE DRAWINGS

FIG. 1 is an illustrative diagram of a wound protecting and fixingdevice in accordance with Embodiment 1 of the present patentapplication.

FIG. 2 is a diagram illustrating the structure of a flexible protectingand fixing layer with an opening;

FIG. 3 is a perspective view of a wound protecting and fixing device inaccordance with Embodiment 2 of the present patent application.

FIG. 4 is a diagram illustrating the structure of a protecting andfixing layer with an opening depicted in FIG. 3.

FIG. 5 is a perspective view of a wound protecting and fixing device inaccordance with Embodiment 3 of the present patent application.

FIG. 6 is a diagram illustrating the structure of a protecting andfixing layer with an opening depicted in FIG. 5.

FIG. 7 is a perspective view of a wound protecting and fixing device inaccordance with Embodiment 4 of the present patent application.

FIG. 8 is a perspective view of a wound protecting and fixing device inaccordance with Embodiment 5 of the present patent application.

FIG. 9 is a perspective view of a wound protecting and fixing device inaccordance with Embodiment 6 of the present patent application.

FIG. 10 is a diagram illustrating the structure of a rigid protectingand fixing layer with an opening having a groove and a slit as depictedin FIG. 9.

FIG. 11 is a perspective view of a wound protecting and fixing device inaccordance with Embodiment 7 of the present patent application.

FIG. 12 is a perspective view of a wound protecting and fixing device inaccordance with Embodiment 8 of the present patent application.

FIG. 13 is a diagram illustrating the structure of a flexible protectingand fixing layer with an opening having a pad as depicted in FIG. 12.

FIG. 14 is a perspective view of a wound protecting and fixing device inaccordance with Embodiment 9 of the present patent application.

FIG. 15 is a diagram illustrating the structure of a protecting andfixing layer with an opening depicted in FIG. 14.

FIG. 16 is a diagram illustrating the structure of a rigid protectingand fixing layer with an opening having a pad depicted in FIG. 14.

FIG. 17 is a structural view of a wound protecting and fixing device inaccordance with Embodiment 10 of the present patent application.

FIG. 18 is a diagram illustrating the structure of a rigid protectingand fixing layer with an opening having a pad and a protruding wingdepicted in FIG. 17.

FIG. 19 is a diagram illustrating the structure of a protecting andfixing layer with an opening depicted in FIG. 17.

FIG. 20 is a structural view of a wound protecting and fixing device inaccordance with Embodiment 11 of the present patent application.

FIG. 21 is a diagram illustrating the structure of a rigid protectingand fixing layer with an opening depicted in FIG. 20.

FIG. 22 is a diagram illustrating the structure of a flexible protectingand fixing layer with an opening depicted in FIG. 20.

FIG. 23 is a perspective view of a wound protecting and fixing device inaccordance with Embodiment 12 of the present patent application.

FIG. 24 is a diagram illustrating a closing and opening member with apad as depicted in FIG. 23.

FIG. 25 is a perspective view of a wound protecting and fixing device inaccordance with Embodiment 13 of the present patent application.

FIG. 26 is an exploded view of a wound protecting and fixing device inaccordance with Embodiment 14 of the present patent application.

In the drawings, the drawing marks are the following:

-   1: protecting and fixing layer with an opening-   11: opening-   12: U shaped cut-   13: passage-   1 a: flexible protecting and fixing layer with an opening-   1 b: rigid protecting and fixing layer with an opening-   1 c: groove-   1 d: slit-   2: closing and opening member-   21: protruding wing-   22: pad-   3: flexible protecting and fixing layer-   31: pad-   4: rigid protecting and fixing layer-   41: pad-   42: protruding wing-   5: supporting member-   A: catheter-   B: wound

DETAILED DESCRIPTION

The basic idea of the present patent application is to provide a woundprotecting and fixing device. Through configuring a protecting andfixing layer with an opening, the opening being defined in theprotecting and fixing layer and configured to extend between an upperplane and a lower plane of the protecting and fixing layer, a wound oran infusion wound being surrounded by the opening or inside a cavityformed by the opening, the following objectives and functions areachieved:

1. Through the protecting and fixing layer with the opening, the openingor the cavity is used to protect and fix the wound so that theprotecting and fixing layer with the opening limits an increase oftension at the wound and a movement-incurred wrinkle of the superficialskin at the wound, thereby preventing wound ripping and rupturing.

2. The protecting and fixing layer with the opening limits amovement-incurred wrinkle of the superficial skin at the woundsurrounded by the opening or the cavity, so that the damage done to thewound by the movement-incurred wrinkle is prevented, and the damage doneto the wound by the relative movement friction between the wound and thedressing without an opening in the conventional technology is prevented.

3. The opening or cavity of the protecting and fixing layer with theopening is configured to protect the wound. So even if the protectingand fixing layer is made by a non-transparent materials, as along as atransparent and detachable closing and opening member is disposed on theupper plane of the opening, the skin will not be hurt when opening,closing or changing the closing and opening member. With suchconfiguration, the wound can be observed any time conveniently, andtreated instantly without changing the whole device so that the damagedone to the wound by moving the catheter and ripping the skin duringchanging the device is prevented and the cost is reduced.

4. Through adjusting the thickness of the protecting and fixing layerwith the opening, or the height or volume of the cavity, the distance orlevel of contact between the dressing on the wound or the protecting andfixing layer with a pad and the surface of the wound can be configuredso as to prevent conglutination and obstruction of blood circulation andsupply caused by the dressing directly and tightly contacting andpressing the wound. It is also possible to configure an absorbingdressing on a wound surface with relatively large amount of secretion asa permeating and absorbing contact surface, so as to make sure thedressing will not conglutinate with the wound tissue and cause furtherdamages while the dressing can absorb the wound secretion.

5. Wound inflammation and infection caused by sweat accumulation underthe thin film and the adhesive irritation, which happens when usingtransparent thin film (PU film) to directly bond and cover infusionwounds in the conventional clinical technologies, is avoided.

6. Through bonding, combining and using protecting and fixing layerswith openings made of different materials, the advantages of each onecan be kept while the disadvantages can be overcome. When the flexibleprotecting and fixing layer is bonded with the rigid protecting andfixing layer while partially overlapping the rigid protecting and fixinglayer, and the boundary of the flexible protecting and fixing layer isalways larger than the boundary of the rigid protecting and fixinglayer, because only the flexible protecting and fixing layer is bondedto the skin as the boundary of the fixing layer, its advantage offlexibly conforming to the surface of the skin and being not likely topeel and fall off is kept. The middle portion of the flexible protectingand fixing layer is bonded with the rigid protecting and fixing layer,while the openings can be anywhere between the two layers. The openingson all the layers are aligned with each other, while the wound is in theopenings and the catheter being fixed is covered and bonded to the skin.This configuration keeps the advantage of the rigid protecting andfixing layer of not generating movement-incurred wrinkles, and overcomesthe problems of catheter displacement, skin wrinkles, wound wrinkles,and the relative displacement frictions between the wounds and thedressing covering the wound caused by movement-incurred wrinkles of theskin or the dragging of an external force when there is only a flexibleprotecting and fixing layer covering and adhering to the catheter or theskin, or when only the opening of the flexible protecting and fixinglayer surrounds the wound. At the same time, the whole surface of therigid protecting and fixing layer is covered by the flexible protectingand fixing layer or only bonded to a middle portion of an upper surfaceof the flexible protecting and fixing layer, so that the disadvantage ofpeeling and falling off easily because of sweat or an increase of woundtension when only the rigid protecting and fixing layer adheres to theskin, is overcome.

7. By combining and bonding protecting and fixing layers with openingsof different material characteristics with wound dressing or protectingand fixing layers of different material characteristics provided by theconventional technology, the disadvantages of the wound dressings orprotecting and fixing layers provided by the conventional technologiesare overcome while the advantages thereof are kept.

For a skilled person in the art to better understand the technicalsolutions of the present application, further detailed descriptions ofthe present patent application will be presented below with theillustrations of the drawings and various embodiments.

Embodiment 1

Referring to FIG. 1 and FIG. 2, a wound protecting and fixing device inthis embodiment includes a protecting and fixing layer 1 with anopening. An opening 11 is defined in the protecting and fixing layer 1and configured to extend between an upper plane and a lower plane of theprotecting and fixing layer 1 along a longitudinal direction. The areaof the opening 11 is compatible with the area of the wound or theinfusion wound so that the wound or the infusion wound is surrounded bythe opening 11 so as to limit an increase of tension at the wound, toprevent the wound from being ripped and ruptured, and to limit amovement-incurred wrinkle of the skin at the wound and/or the opening ofthe wound.

An adhesive layer may be disposed at a lower surface of the protectingand fixing layer with the opening, or the protecting and fixing layermay be covered and bonded with a dressing made by conventionaltechnologies (such as a non-woven dressing with a pad or transparentthin film) and thereby fixed to the skin around the wound. In thisembodiment, the protecting and fixing layer with the opening isrelatively thick.

In another embodiment, the protecting and fixing layer with the openingincludes a flexible protecting and fixing layer with an opening and arigid protecting and fixing layer with an opening. The flexibleprotecting and fixing layer with the opening may be a transparent thinfilm (PU film) and ultra-thin. Referring to FIG. 2, the flexibleprotecting and fixing layer with the opening is configured to tightlycontact the skin, the object to be fixed, and the rigid protecting andfixing layer with the opening and not to fall off easily. The rigidprotecting and fixing layer with the opening may be made of plastic,silicon gel, thickened non-woven cloth, foam, and hydrocolloid, andgenerally relatively thick, referring to FIG. 1. Generally, the rigidprotecting and fixing layer with the opening is relatively thick, whilethe opening forms a cavity with a certain height and volume so as tolimit an increase of tension at the wound surrounded by the opening orthe cavity and a movement-incurred wrinkle of the superficial skin,prevent wound rips and ruptures, prevent damages from being done to thewound by the movement-incurred wrinkles of the wound superficial skinand the displacement of the catheter being fixed, and prevent damagesfrom being done to the wound by the relative displacement frictionsbetween the wound and the dressing. In addition, through adjusting thethickness of the protecting and fixing layer with the opening, or theheight or volume of the cavity, the distance or level of contact betweenthe dressing on the wound or the protecting and fixing layer with a padand the surface of the wound can be configured so as to avoidconglutination and obstructions of blood circulation and supply causedby the dressing directly and tightly contacting and pressing the surfaceof the wound. It is also possible to configure an absorbing dressing ona wound surface with relatively a large amount of secretion as apermeating and absorbing contact surface, so as to make sure thedressing will not conglutinate with the wound tissue and cause furtherdamages while the dressing can absorb the wound secretion.

In this embodiment, the opening of the protecting and fixing layer withthe opening is configured to protect the wound. So even if theprotecting and fixing layer is made by a non-transparent material, asalong as a transparent and detachable closing and opening member isdisposed on the upper plane of the opening, the skin will not be hurtwhen opening, closing or changing the closing and opening member. Withsuch configuration, the wound can be observed any time conveniently, andtreated instantly without changing the whole device so that the damagedone to the wound by moving the catheter and ripping the skin duringchanging the device is prevented and the cost is reduced. Woundinflammation and infection caused by sweat accumulation under the thinfilm and the adhesive irritation, which happens when using transparentthin film (PU film) to directly bond and cover infusion woundsclinically in the conventional technology, is avoided.

Embodiment 2

Referring to FIG. 3 and FIG. 4, a wound protecting and fixing deviceaccording to this embodiment includes a protecting and fixing layer withan opening 1 and a closing and opening member 2. The opening 11 of theprotecting and fixing layer is aligned with the infusion wound whilecovering and bonding a catheter A onto the skin. The closing and openingmember 2 is configured to seal the opening 11, so that the infusionwound is sealed and separated from the outside. A U shaped cut 12 isdefined at an outer edge of the protecting and fixing layer with theopening, and configured to make the catheter being fixed be betterconforming to the skin. The closing and opening member 2 is fixed withthe protecting and fixing layer with the opening through an adhesivelayer, which is disposed on a lower edge of the closing and openingmember. Under an external force, the closing and opening member ispartially or completely detached, so that a cavity 11 is exposed to theoutside. The closing and opening member 2 includes a protruding wing 21disposed at an edge thereof. The configuration of this protruding wingmakes it convenient for a human hand or a mechanical tool to exert forceto the closing and opening member. In operation, the human hand can workon this protruding wing, and thereby pull up and lay down the closingand opening member.

The protecting and fixing layer with the opening in this embodiment ismade of an ultra-thin flexible material.

The closing and opening member 2 in this embodiment may be made of atransparent or non-transparent material. There is no adhesive in thearea corresponding to the sealed cavity, so as to avoid infection causedby direct irritation made by the adhesive to the infusion wound. Theprotruding wing 21 is disposed at the edge of closing and opening member2 so that the opening of the fixing layer can be sealed and opened anytime conveniently, the infusion wound can be handled without changingthe flexible protecting and fixing layer with the opening, and thedamage to the infusion wound as well as skin irritation caused by movingthe catheter during changing and peeling can be avoided. The operationof the embodiment is simple, while the frequency of changing thedressing is reduced and the cost is saved.

The catheter in this embodiment includes central venous catheters (CVC),peripherally inserted central catheters (PICC), vein retaining needlecatheters, drainage tubes and etc.

Embodiment 3

Referring to FIG. 5 and FIG. 6, the difference between this embodimentand Embodiment 2 is that the protecting and fixing layer with theopening 1 is made of a rigid material such as plastic, silicon gel,foam, hydrocolloid, thickened non-woven cloth and so on, and isrelatively thick, which makes the opening 11 have a clear height andform a cavity. A passage 13 connecting the cavity to the outside isdefined in the protecting and fixing layer with the opening 1. Acatheter A is disposed in the passage 13, and fixed to the skin throughan adhesive layer at a lower surface of the protecting and fixing layerwith the opening 1. The opening 11 surrounds the infusion wound and aclosing and opening member 2 seals the opening from the top.

The opening 11 in this embodiment can surround the wound so that thesurface of the wound and the skin around the wound are surrounded by theedge of the cavity 11, thereby wound ripping and rupturing can beeffectively prevented, the substantial part of the rigid protecting andfixing layer with the opening can be prevented from contacting thesurface of the wound directly, and the wound is in a cavity formed bythe opening where no object can touch. The rigid protecting and fixinglayer with the opening is configured to limit the movement-incurredwrinkles of the superficial skin of the wound in the opening 11 or thecavity, so as to better protect the wound and eliminate contact andfrictions with foreign objects and contact inflammation responses. Theclosing and opening member 2 is made of a transparent material so as tomake it convenient to observe the wound situation and handle the woundany time without changing the whole device.

Embodiment 4

Referring to FIG. 7, being different from the above embodiments, in thisembodiment, the wound protecting and fixing device includes a protectingand fixing layer with an opening and an closing and opening member,wherein the protecting and fixing layer with the opening includes aflexible protecting and fixing layer with an opening 1 a, a rigidprotecting and fixing layer with an opening 1 b, and a closing andopening member 2. Through cooperatively using the flexible protectingand fixing layer with the opening 1 a and the rigid protecting andfixing layer with the opening 1 b, the infusion wound is protected andfixed and the catheter is fixed. The opening of the flexible protectingand fixing layer 1 a is aligned with the infusion wound, and then thecatheter A is covered and bonded to the skin around the wound so thatthe catheter A is fixed and the infusion wound is surrounded by theflexible protecting and fixing layer 1 a. The rigid protecting andfixing layer with the opening 1 b is bonded and fixed to an uppersurface of the flexible protecting and fixing layer with the opening 1a, while the boundary of the flexible protecting and fixing layer withthe opening 1 a is larger than the boundary of the rigid protecting andfixing layer with the opening 1 b. Therefore, for the whole device, onlythe flexible protecting and fixing layer 1 a is bonded to the skin, thecatheter A is bonded and fixed between the skin and the flexibleprotecting and fixing layer with the opening, the infusion wound is inthe opening or cavity formed by the two protecting and fixing layers,and the closing and opening member seals the opening or cavity.

In this embodiment, because the flexible protecting and fixing layerwith the opening 1 a and the rigid protecting and fixing layer with theopening 1 b are cooperatively used to protect and fix infusion wounds orregular wounds and prevent wound rupturing, the respective advantages ofthe flexible protecting and fixing layer with the opening 1 a and therigid protecting and fixing layer with the opening 1 b are utilizedwhile the disadvantages thereof are overcome, the catheter fixture ismore secure, the protection of infusion wound is more effective, thetime period for the device to be used for once is longer, the number oftimes of changing the device is fewer, and the cost is saved.

In this embodiment, the flexible protecting and fixing layer with theopening 1 a is bonded with the rigid protecting and fixing layer withthe opening 1 b while not completely overlapping the rigid protectingand fixing layer with the opening 1 b, and the boundary of the flexibleprotecting and fixing layer with the opening 1 a is always larger thanthe boundary of the rigid protecting and fixing layer with the opening 1b. Because only the flexible protecting and fixing layer is bonded tothe skin as the boundary of the fixing layer, the flexible protectingand fixing layer flexibly conforms to the surface of the skin and doesnot easily peel and fall off. The middle portion of the flexibleprotecting and fixing layer with the opening 1 a is bonded with therigid protecting and fixing layer with the opening 1 b, while theinfusion wound is in the cavity jointly formed by the two layers, andthe catheter being fixed is covered and bonded to the skin. Thisconfiguration keeps the advantage of the rigid protecting and fixinglayer of not generating movement-incurred wrinkles, and overcomes theproblems of catheter A's displacement, skin wrinkles, wound wrinkles,and the relative displacement frictions between the wound and thedressing covering the wound, caused by movement-incurred wrinkles of theskin or the dragging of an external force, when there is only a flexibleprotecting and fixing layer with the opening 1 a covering and adheringto the catheter A or the skin, or when only the opening of the flexibleprotecting and fixing layer 1 a surrounds the wound, so that theinfusion wound is not damaged thereby. At the same time, the wholesurface of the rigid protecting and fixing layer with the opening 1 b isbonded to a middle portion of an upper surface of the flexibleprotecting and fixing layer with the opening 1 a, so that thedisadvantage of peeling and falling off easily because of sweat or woundtension when only the rigid protecting and fixing layer with the opening1 b adheres to the skin is overcome.

Embodiment 5

Referring to FIG. 8, the difference between this embodiment andEmbodiment 4 is that the flexible protecting and fixing layer with theopening and the rigid protecting and fixing layer with the openingexchanges their positions so that the flexible protecting and fixinglayer with the opening 1 a is disposed at an upper position while therigid protecting and fixing layer with the opening 1 b is disposed underthe flexible protecting and fixing layer with the opening 1 a. Theclosing and opening member 2 seals the opening of the flexibleprotecting and fixing layer with the opening 1 a. Such structure andconfiguration enhance the waterproof function.

Embodiment 6

Referring to FIG. 9 and FIG. 10, the difference between this embodimentand Embodiment 4 is that a groove 1 c is disposed at the surface of theedge of the opening of the rigid protecting and fixing layer 1 b withthe opening. The groove 1 c is configured to facilitate the placement ofthe catheter. In addition, a through slit 1 d is disposed between theboundary of the rigid protecting and fixing layer 1 b with the openingand the opening. Through the slit 1 d, the rigid protecting and fixinglayer 1 b with the opening surrounds the infusion wound between the skinand the catheter, so that the infusion wound is in the cavity formed bythe opening, and the catheter is disposed on the rigid protecting andfixing layer 1 b with the opening through the groove, thereby avoidingdamages from being done by the catheter pressing the skin for a longtime, especially for children's skin.

In this embodiment, the rigid protecting and fixing layer with theopening 1 b works as a supporting pad of the catheter. The flexibleprotecting and fixing layer with the opening 1 a covers and bonds thecatheter and the rigid protecting and fixing layer with the opening 1 b.The boundary of the flexible protecting and fixing layer 1 a with theopening extends and adheres to the surface of the skin thereby fixingthe whole device securely. The opening is sealed by the closing andopening member 2 from the top. Such configuration also enhances thewaterproof function while the other functions are the same as inEmbodiment 4.

Embodiment 7

Referring to FIG. 11, in this embodiment, the wound protecting andfixing device includes a rigid protecting and fixing layer 1 with anopening and a flexible protecting and fixing layer 3 without an opening.This embodiment is mainly used for short term protection and fixing ofinfusion wounds, and requires changing the whole device when beingchanged, the advantage of which is strong waterproof capability. Theother functions are the same as in Embodiment 6.

Embodiment 8

Referring to FIG. 12 and FIG. 13, the difference between this embodimentand Embodiment 7 is that in this embodiment, the flexible protecting andfixing layer 3 includes a pad 31. Through the pad 31 absorbing oozedliquid and leaked blood of the infusion wounds, the device is applicableto infusion wounds that are recently established. The other functionsare the same as in Embodiment 7.

Embodiment 9

Referring to FIG. 14, FIG. 15 and FIG. 16, a wound protecting and fixingdevice according to this embodiment includes a flexible protecting andfixing layer 1 with an opening and a rigid protecting and fixing layer 4with a pad. The pad 41 is included in the rigid protecting and fixinglayer 4 and disposed at a lower portion thereof. A slit 1 d is definedbetween the opening 11 of the protecting and fixing layer 1 and an edgethereof. The opening 11 of the protecting and fixing layer 1 surroundsthe infusion wound, and the protecting and fixing layer 1 adheres to theskin. The catheter is disposed on an upper surface of the protecting andfixing layer 1. The rigid protecting and fixing layer 4 with the padcovers and bonds the catheter to the upper surface of the protecting andfixing layer 1 so as to fix the catheter. In this embodiment, becausethe rigid protecting and fixing layer 4 with the pad adheres to the topof the protecting and fixing layer 1, it is more securely fixed than thecase in the conventional technology where only the rigid protecting andfixing layer 4 is used. The pad 41 of the rigid protecting and fixinglayer 4 with the pad is configured to absorb the oozed liquid of thewound and mainly used for protecting infusion wound that has recentlybeen punctured. A protruding wing 42 is disposed on a corner of an outerboundary of the rigid protecting and fixing layer 4, and configured forpeeling off and changing the rigid protecting and fixing layer. In thisembodiment, the rigid protecting and fixing layer 4 is not transparent,but is air permissive and capable of absorbing oozed liquid so thatinfection caused by sweat accumulation at the wound in the case whereonly a transparent thin film is used for protection and fixing isavoided. This embodiment is mainly applicable to protecting newlyestablished and short-term infusion wounds, and fixing the catheter inthose cases.

Embodiment 10

Referring to FIG. 17, FIG. 18 and FIG. 19, a wound protecting and fixingdevice according to this embodiment includes a protecting and fixinglayer 1 with an opening made of a flexible material and a rigidprotecting and fixing layer 4 with a pad. The opening 11 of the flexibleprotecting and fixing layer 1 is aligned with a wound B and adhering tothe skin around the wound B. The rigid protecting and fixing layer 4with a pad is then covered onto the wound and bonded with the protectingand fixing layer 1 with the opening. In this embodiment, the protectingand fixing layer 1 enhances the fixing security of the rigid protectingand fixing layer 4 and the embodiment is especially applicable to woundsat the movable joint parts. Skin wrinkles caused by any movement willnot make the wound protecting and fixing device be detached and fall offfrom the skin. A protruding wing 42 is disposed at an edge of the rigidprotecting and fixing layer 4 and configured to make it convenient topeel off the rigid protecting and fixing layer 4 and change the rigidprotecting and fixing layer 4, while keeping the flexible protecting andfixing layer 1 a with the opening unchanged at the same time.

Embodiment 11

Referring to FIG. 20, FIG. 21 and FIG. 22, a wound protecting and fixingdevice according to this embodiment includes a protecting and fixinglayer with an opening and a closing and opening member 2. The protectingand fixing layer with the opening includes a flexible protecting andfixing layer with an opening 1 a and a rigid protecting and fixing layerwith an opening 1 b. In this embodiment, the opening of the rigidprotecting and fixing layer 1 b accommodates a wound B, limits theincrease of tension of the wound B, prevents the wound B from beingripped and ruptured, limits the wound damage caused by movement-incurredwrinkles of the superficial skin of the wound B, prevents bloodcirculation obstruction and inflammatory responses due to foreign objectcontact caused by a foreign object tightly pressing and contacting thewound B. Through the transparent closing and opening member 2, thehealing situation of the wound B can be monitored any time, whiledebriding, sanitization, drainage, and regional medical and physicaltreatment may be conducted to the wound B without changing the wholeprotecting and fixing device.

Embodiment 12

Referring to FIG. 23 and FIG. 24, the difference between this embodimentand Embodiment 11 is that a pad 22 is disposed under a lower surface ofthe closing and opening member 2. The pad 22 has functions such asstrong absorption and antibiosis capabilities. Through adjusting theheight or volume of the cavity of the rigid protecting and fixing layer1 b with the opening, the distance or level of contact between the pad22 in the cavity above the wound and the surface of the wound can beconfigured so as to avoid conglutination and blood circulation andsupply obstructions caused by the pad 22 directly and tightly contactingand pressing the surface of the wound. It is also possible to configurethe pad 22 to be a permeating and absorbing contact surface to the woundsurface, so as to make sure the pad 22 will not conglutinate with thewound tissue and cause further damages while the pad 22 can absorb thewound secretion. In this embodiment, the pad 22 disposed under theclosing and opening member 2 is also suitable for protecting and fixinginfusion wounds and having the same functions. The other functions arethe same as in Embodiment 11.

Embodiment 13

Referring to FIG. 25, in this embodiment a wound protecting and fixingdevice includes a protecting and fixing layer with an opening. Theprotecting and fixing layer with the opening includes a flexibleprotecting and fixing layer 1 a with an opening, and a rigid protectingand fixing layer 1 b with an opening below the flexible protecting andfixing layer la with the opening. The rigid protecting and fixing layer1 b with the opening has a shape of truncated cone. The flexibleprotecting and fixing layer 1 a with the opening covers and adheres tothe skin. A closing and opening member 2 is disposed at the opening.This configuration, besides keeping the functions that it should have,is mainly for making the flexible protecting and fixing layer with theopening conform to the skin surface and fixed to the wound skin well,while increasing the height of the cavity. At the same time, the area ofthe bottom of the rigid protecting and fixing layer with the opening isreduced and the material cost is saved.

Embodiment 14

Referring to FIG. 26, in this embodiment a wound protecting and fixingdevice includes a protecting and fixing layer with an opening. Theprotecting and fixing layer with the opening includes two flexibleprotecting and fixing layers 1 a with openings, a rigid protecting andfixing layer 1 b with an opening, and an closing and opening member 2. Asupporting member 5 is disposed on an upper portion of the rigidprotecting and fixing layer 1 b with the opening. The supporting member5 has bar shape and is disposed above the rigid protecting and fixinglayer 1 b with the opening, extending to a side wall of the rigidprotecting and fixing layer with the opening and being fixed thereto.The supporting member is made of a material that has certain rigidityand does not deform easily, such as silicon gel, PVC materials or otherplastics. The purpose of setting up the supporting member is to enhancethe fixture of the rigid protecting and fixing layer with the opening,and prevent the closing and opening member from collapsing and touchingthe wound. Especially for relatively large wound surface, setting up thesupporting member is particularly necessary.

In above embodiments, the cavity in the rigid protecting and fixinglayer with the opening is configured to connect the upper surface andthe lower surface of the rigid protecting and fixing layer with theopening all the way through the rigid protecting and fixing layer withthe opening. In practice, the cavity in the rigid protecting and fixinglayer with the opening may be configured to only connect with the lowersurface, thereby forming an opening on the lower surface, and not toconnect with the upper surface so that there is no opening formed on theupper surface.

While the present patent application has been shown and described withparticular references to a number of embodiments thereof, thedescriptions made to the embodiments are intended to illustrate themethod and the core idea of the present invention. It should be notedthat various other improvements or modifications may be made withoutdeparting from the scope of the present invention, and theseimprovements and modifications are also in the scope of protection ofthe claims.

What is claimed is:
 1. A wound protecting and fixing device comprising:at least a protecting and fixing layer with an opening; and a closingand opening member disposed at the protecting and fixing layer with theopening; wherein: the opening is defined in the protecting and fixinglayer and configured to extend between an upper plane and a lower planeof the protecting and fixing layer along a longitudinal direction, andto surround a wound therein; the protecting and fixing layer with theopening comprises a flexible protecting and fixing layer with an openingand a rigid protecting and fixing layer with an opening, the flexibleprotecting and fixing layer having a planar shape, the rigid protectingand fixing layer having a planar shape and a rigidity greater than arigidity of the flexible protecting and fixing layer, the rigidprotecting and fixing layer being configured for limiting an increase oftension at the wound and a movement-incurred wrinkle of skin at thewound, a cavity being defined inside and extending through material ofthe rigid protecting and fixing layer and accommodating the wound, thecavity being embedded and confined within the material of the rigidprotecting and fixing layer without extending beyond the material of therigid protecting and fixing layer; the flexible protecting and fixinglayer and the rigid protecting and fixing layer are bonded together andaligned by the openings; and the closing and opening member isconfigured to close or open the opening, and detachably fixed with theupper plane of the protecting and fixing layer with the opening throughan adhesive layer.
 2. The wound protecting and fixing device of claim 1further comprising an adhesive layer, the adhesive layer being disposedon a surface of the protecting and fixing layer with the opening.
 3. Thewound protecting and fixing device of claim 1, wherein the flexibleprotecting and fixing layer is configured to follow a movement-incurredwrinkle of a texture of superficial skin that the flexible protectingand fixing layer adheres to and produce the same movement-incurredwrinkle, and the rigid protecting and fixing layer is configured tolimit a movement-incurred wrinkle of the skin that the rigid protectingand fixing layer adheres to, a movement-incurred wrinkle of the flexibleprotecting and fixing layer, a wound rupture surrounded by the opening,and a movement-incurred wrinkle of superficial skin of the wound.
 4. Thewound protecting and fixing device of claim 1 further comprising a pad,the pad being disposed under a lower surface of the closing and openingmember.
 5. The wound protecting and fixing device of claim 1, whereinthe closing and opening member comprises a protruding wing disposed atan edge thereof.
 6. The wound protecting and fixing device of claim 1,wherein a passage connecting the cavity to the outside is defined in therigid protecting and fixing layer with the opening, the passage beingconfigured to allow an object to enter or exit the cavity.
 7. The woundprotecting and fixing device of claim 1, wherein a longitudinalcross-section of the rigid protecting and fixing layer with the openinghas a trapezoid shape.
 8. The wound protecting and fixing device ofclaim 1, wherein the flexible protecting and fixing layer with theopening is disposed below or above the rigid protecting and fixing layerwith the opening, an outer boundary of the flexible protecting andfixing layer with the opening being extending beyond an outer boundaryof the rigid protecting and fixing layer with the opening.
 9. The woundprotecting and fixing device of claim 1, wherein a U shaped cut isdefined at an outer edge of the protecting and fixing layer with theopening.
 10. The wound protecting and fixing device of claim 1 furthercomprising a supporting member, the supporting member being fixed withat least an upper portion of the protecting and fixing layer with theopening.
 11. The wound protecting and fixing device of claim 10, whereinthe supporting member is a supporting bar, a supporting chip, asupporting block, or a supporting frame.
 12. The wound protecting andfixing device of claim 1, wherein the protecting and fixing layer withthe opening is a combination of multiple layers of different materials.13. The wound protecting and fixing device of claim 1, wherein an outeredge of the protecting and fixing layer with the opening is connected tothe opening through a slit.
 14. The wound protecting and fixing deviceof claim 1, wherein the flexible protecting and fixing layer has firstand second surfaces opposite to each other, the first surface isundetachably bonded to the rigid protecting and fixing layer, and thesecond surface is detachably fixed to the closing and opening member.15. The wound protecting and fixing device of claim 14, wherein theflexible protecting and fixing layer has a perimeter greater than aperimeter of the rigid protecting and fixing layer, and the flexibleprotecting and fixing layer and the rigid protecting and fixing layerare configured to directly contact the skin.
 16. The wound protectingand fixing device of claim 15, wherein the rigid protecting and fixinglayer has a thickness greater than a thickness of the flexibleprotecting and fixing layer.
 17. The wound protecting and fixing deviceof claim 16, wherein the rigid protecting and fixing layer furthercomprises: a slit extending from a boundary of the rigid protecting andfixing layer to an edge of the opening of the rigid protecting andfixing layer, and a groove at the edge of the opening of the rigidprotecting and fixing layer for inserting a catheter, and the flexibleprotecting and fixing layer further comprises a U-shaped cut at an outeredge of the flexible protecting and fixing layer, the U-shaped cut beingaligned to the groove of the rigid protecting and fixing layer.
 18. Thewound protecting and fixing device of claim 14, wherein the flexibleprotecting and fixing layer has a perimeter greater than a perimeter ofthe rigid protecting and fixing layer, and the rigid protecting andfixing layer has a thickness greater than a thickness of the flexibleprotecting and fixing layer.
 19. The wound protecting and fixing deviceof claim 18, further comprising another flexible protecting and fixinglayer with an opening, wherein said another flexible protecting andfixing layer is bonded to the rigid protecting and fixing layer on aside opposite to a side bonded with the flexible protecting and fixinglayer, and configured to directly contact the skin.
 20. The woundprotecting and fixing device of claim 19, further comprising asupporting member disposed between the flexible protecting and fixinglayer and the rigid protecting and fixing layer, and extending from onesidewall of the rigid protecting and fixing layer to another sidewall ofthe rigid protecting and fixing layer.